On January 14, 2020 Celsee, Inc., a leading provider of single-cell isolation technology, and Kindstar Global, the largest medical esoteric testing service group in China, reported a purchase agreement to provide scientists at the Kindstar Laboratory System in China with Celsee’s Genesis System for monitoring circulating tumor cells (CTCs) in lung, breast, and bladder cancers as well as single-cell research (Press release, Celsee, JAN 14, 2020, View Source [SID1234553186]). In addition, Kindstar will become a distributor of Celsee’s products in China.

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For this cancer research, Kindstar scientists will use the BioINK kit, which was developed by IncellDx for CTC enumeration in therapeutic monitoring and is performed on Celsee’s Genesis System utilizing the Celselect Technology. Now, researchers will gain access to Celsee’s Genesis System, which has better capture efficiency and detection of CTCs compared to other CTC enumeration platforms.

"Kindstar Global is leading the way for oncology research and testing in China, and we are committed to implementing the most advanced tools for that work," said Dr. Shiang Huang, Founder and CEO of Kindstar. "We are truly impressed by the capabilities of Celsee’s single-cell isolation and enumeration technology and are eager to use it in our own laboratories as well as to make it available to scientists throughout China."

John Stark, Chief Executive Officer of Celsee, commented: "We are very excited to announce the partnership with Kindstar and the opportunity to bring Celsee technology to the clinical research market in China. Our team has worked closely with IncellDx to develop workflows that combine our single-cell tools with their flow cytometry classification assays and BioINK assays for CTC enumeration to assess disease progression and response to therapy."

Celsee’s technology enables high-throughput analysis of single cells with industry-leading capture rates. The Genesis System supports two slide technologies. Celselect slides enrich and enumerate CTCs with high capture efficiency and detection rates. Celsingle slides use a gentle, gravity-based method to capture and isolate thousands of individual cells while maintaining viability and structural integrity for robust downstream analysis in both genomic and proteomic applications and improved sensitivity compared to other single-cell technologies.

On January 14, 2020 Caris Life Sciences, a leading innovator in molecular science focused on fulfilling the promise of precision medicine, reported that The Preston Robert Tisch Brain Tumor Center at Duke University Hospital has become the 32nd member of its Precision Oncology Alliance (Press release, Caris Life Sciences, JAN 14, 2020, View Source [SID1234553203]). The Alliance is a collaborative network of leading cancer centers that demonstrates a commitment to precision medicine. These centers work together toward a common goal to advance tumor profiling and establish standards of care for molecular testing in oncology.

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The Preston Robert Tisch Brain Tumor Center was one of the first brain tumor research and clinical programs in the United States. Since then, it has advanced to become one of the best pediatric and adult neuro-oncology programs in the world—leading the way in comprehensive care that combines research breakthroughs, clinical trials and the newest therapies. The National Cancer Institute (NCI) has given the center the highest rating of "exceptional" for each of the last 15 years.

The mission of the Center is to provide hope and empower brain tumor patients with unparalleled care, research and education. The Center sees up to 900 new adult brain tumor patients and up to 75 new pediatric brain tumor patients per year from across the country and around the world.

"We are excited to welcome Preston Robert Tisch Brain Tumor Center into the Precision Oncology Alliance," said Brian J. Brille, Vice Chairman of Caris Life Sciences. "The Preston Robert Tisch Brain Tumor Center is globally recognized for its collaborative spirit and commitment to its patients and we expect this partnership with the Alliance members to help further progress the potential of molecular profiling."

Through the Precision Oncology Alliance – powered by Caris – The Preston Robert Tisch Brain Tumor Center will partner with other notable cancer centers and academic institutions to broaden patient access to precision cancer care, have early access to Caris’ Next Generation Profiling offerings, and establish evidence-based standards for tumor profiling and molecular testing in oncology. By leveraging the comprehensive genomic and proteomic tumor profiling services available through the Caris Molecular Intelligence platform, oncologists from the Center will be able to prioritize therapeutic options and determine which clinical trial opportunities may benefit their patients. Additionally, the Center’s researchers will partner with other Alliance members to contribute to and publish data and advance collaborative clinical trials.

"We are well known for pioneering cancer research that results in optimal, individualized treatment," said David Ashley, Ph.D., a Neuro-oncologist and Pediatric Neuro-oncologist at Duke Cancer Center. "We look forward to collaborating with Caris Life Sciences and the members of the Precision Oncology Alliance to fuel the next great discoveries in precision medicine."

The Precision Oncology Alliance comprises 32 academic, hospital and community-based cancer institutions, including ten NCI-designated Comprehensive Cancer Centers. The Alliance now includes over 1,350 physicians, spanning more than 400 locations, who provide services for over 280,000 people with cancer each year. Precision Oncology Alliance members also have access to Caris Pharmatech’s oncology trial network, which can help reduce the time it takes to identify and connect appropriate patients with novel targeted cancer therapies in clinical development.

On January 14, 2020 Singapore-based precision oncology startup Lucence, reported on the heels of its series A funding, is sharing early data highlighting the capabilities of its liquid biopsy technology to detect somatic variants in patients with blood cancers, with excellent matching between bone marrow and blood (Press release, Lucence, JAN 14, 2020, View Source [SID1234553187]). Lucence’s amplicon-based sequencing technology, known as AmpliMARK, can provide high sensitivity mutation detection in blood for multiple solid tumor types. This new study data demonstrates the performance of AmpliMARK in hematological malignancies, and suggests that it can provide high resolution, target-rich insights for clinicians and patients to better, and less invasively, manage these diseases.

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Liquid biopsy aims to use blood as a platform for cancer screening, diagnosis, treatment, and monitoring. In the case of hematological malignancies like leukemia, current bone marrow-based tests for detecting and monitoring disease progression offer limited sensitivity and are highly invasive. Lucence’s findings suggest that a blood-based liquid biopsy test could be a compelling, highly sensitive clinical alternative to these tests.

Lucence’s poster highlighting their recent study results, Ultrasensitive Detection of Diverse Genomic Alterations in Hematological Malignancies using a Targeted Amplicon-based Sequencing Approach, will be presented Tuesday, January 14th at 4:15 pm Eastern Time at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Advances in Liquid Biopsies meeting in Miami. Based on a study of 65 patients with hematological malignancies, including acute myeloid leukemia, myelodysplastic syndromes, and multiple myeloma, the poster reports high sensitivity of AmpliMARK in detecting genomic alterations in blood and bone marrow samples. The study results show that AmpliMARK detects mutations at a sensitivity down to 0.1% variant allelic frequencies (VAF) and fusion genes like BCR-ABL1 down to 1% VAF. The results also show excellent concordance between bone marrow and blood, suggesting blood could be a viable medium of detection when marrow is challenging to obtain.

AmpliMARK uses a unique molecular bar-code and error correction technology that improves test sensitivity across multiple mutation types for single nucleotide variants and fusion genes. AmpliMARK is the foundational breakthrough technology in Lucence’s offering of blood-based tests for both profiling hematological and solid tumors.

Dr. Zi Yi Lim, senior consultant haematologist at the Centre for Clinical Haematology and study co-author, said, "Molecular diagnostics are an essential part of the workup and an important follow up tool in patients with blood cancers. Bone marrow assessments remain the gold standard investigation to evaluate the genomic disease profile of these patients. However, bone marrow assessments are costly, invasive and uncomfortable for the patient. The finding that Lucence’s technology can detect even low-level mutations in peripheral blood of patients with a high level of concordance to bone marrow is an exciting development. This could facilitate more convenient, cost-effective and regular disease assessments of such patients with a blood test."

Lucence is currently preparing to open their Silicon Valley laboratory to make their liquid biopsy tests more widely available to US clinicians and patients. While the Company’s initial focus in the US will be in profiling late-stage lung cancer patients for treatment selection, the data presented at the AACR (Free AACR Whitepaper) conference provides early validation of the core technology of Lucence’s liquid biopsy tests. Lucence announced their $20 million Series A led by IHH Healthcare, one of the world’s largest integrated private healthcare groups, in November 2019, and their executive team will be attending the upcoming 38th Annual J.P. Morgan Healthcare Conference in San Francisco.

On January 14, 2020 Boston Scientific Corporation (NYSE: BSX) generated sales, reported that based upon preliminary unaudited financial information, of approximately $2.90 billion during the fourth quarter of 2019 (Press release, Boston Scientific Nordic, JAN 14, 2020, View Source [SID1234553204]). This represents growth of approximately 13.4 percent on a reported basis, compared to the company’s guidance range of 13 to 15 percent; approximately 14.1 percent on an operational1 basis, compared to the company’s guidance range of 14 to 16 percent; and approximately 7.3 percent on an organic2 basis, compared to the company’s guidance range of 8 to 9 percent, all compared to the prior year period.

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For the full year 2019, the company generated sales, based upon preliminary unaudited financial information, of approximately $10.74 billion. This represents growth of approximately 9.3 percent on a reported basis, compared to the company’s guidance range of 9 to 9.5 percent; approximately 11.1 percent on an operational basis, compared to the company’s guidance range of 11 to 11.5 percent; and approximately 7.3 percent on an organic basis, compared to the company’s guidance of approximately 7.5 percent, all compared to the prior year period.

Preliminary net sales for the fourth quarter by business and region:

Sales growth rates that exclude the impact of foreign currency fluctuations and/or the impact of recent acquisitions and divestitures with significant sales are not prepared in accordance with U.S. GAAP.

While the company is still conducting financial closing procedures for the fourth quarter and full year, the company estimates that it will exceed its previously issued guidance for earnings of $0.22 to $0.25 for the fourth quarter and $0.72 to $0.75 per share for the full year 2019, on a GAAP per share basis, primarily due to a significant non-cash tax benefit arising from an intra-entity asset transfer of intellectual property completed in the fourth quarter of 2019. The company estimates adjusted earnings, excluding certain charges (credits), will be within its previously issued guidance range of $0.42 to $0.45 per share for the fourth quarter of 2019 and a range of $1.55 to $1.58 per share for the full year 2019.

All of the information in this press release is preliminary and subject to completion of year-end financial reporting processes, reviews and audit.

1. Operational revenue growth excludes the impact of foreign currency fluctuations.

2. Organic revenue growth excludes the impact of foreign currency fluctuations and sales from the recent acquisitions of NxThera, Inc., Claret Medical, Inc., Augmenix, Inc., Vertiflex, Inc. and BTG plc (BTG), each with no prior year comparable sales. Organic revenue growth also excludes the impact of the divestiture of our global embolic microspheres portfolio, a transaction entered into in connection with obtaining the antitrust clearances required to complete the BTG transaction.

3. We have three historical reportable segments comprised of Medical Surgical (MedSurg), Rhythm and Neuro, and Cardiovascular, which represent an aggregation of our operating segments that generate revenues from the sale of medical devices (Medical Devices). As part of our acquisition of BTG on August 19, 2019, we acquired an Interventional Medicine business, which is now included in our Peripheral Interventions operating segment’s 2019 revenues from August 19, 2019 through December 31, 2019.

4. As part of our acquisition of BTG on August 19, 2019, we acquired a specialty pharmaceuticals business (Specialty Pharmaceuticals). Subsequent to acquisition, Specialty Pharmaceuticals is now a stand-alone operating segment presented alongside our Medical Device reportable segments. Specialty Pharmaceuticals net sales are substantially U.S. based. Our chief operating decision maker (CODM) reviews financial information of our globally managed Specialty Pharmaceuticals operating segment at the worldwide level without further disaggregation into regional results. As such, Specialty Pharmaceuticals net sales are presented globally, and our Medical Devices reportable segments regional net sales results do not include Specialty Pharmaceuticals.

J.P. Morgan Healthcare Conference on Tuesday, January 14, 2020
Also as previously announced, Boston Scientific will participate in the J.P. Morgan Healthcare Conference today in San Francisco. Mike Mahoney, chairman and chief executive officer, will present at approximately 8:00 a.m. PST. At 8:30 a.m. PST, Mike will be joined by Dan Brennan, executive vice president and chief financial officer, Dr. Ian Meredith, executive vice president and global chief medical officer, and Susie Lisa, vice president, Investor Relations, in a question-and-answer session with the host analyst and audience members.

A live webcast of the presentation and question-and-answer session will be available on the Investor Relations section of the Boston Scientific website at investors.bostonscientific.com. A replay of the webcast will be accessible at investors.bostonscientific.com beginning approximately one hour following the completion of the event.

Conference Call on Wednesday, February 5, 2020
As previously announced, Boston Scientific will webcast its conference call discussing financial results and business highlights for the fourth quarter and full year 2019 and provide first quarter and full year 2020 guidance on Wednesday, February 5, 2020 at 8:00 a.m. EST. A live webcast of the conference call will be available on the Investor Relations section of the website at investors.bostonscientific.com. A replay of the webcast will be archived and available at investors.bostonscientific.com beginning approximately one hour following the completion of the meeting.

On January 14, 2020 BostonGene Corporation (BostonGene), a biomedical software company, reported its collaboration with the Vaccine and Immunotherapy Center (VIC) at Massachusetts General Hospital (Press release, BostonGene, JAN 14, 2020, View Source [SID1234553189]).

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BostonGene performs a computational analysis of a patient’s genomics and transcriptomics data from solid tumors including Lung Cancer and Head and Neck Cancer. In parallel, MGH VIC team conducts mass cytometry analysis of tissue of same patients. A correlation analysis is then employed to demonstrate the power of the computational algorithms in the assessment of the intratumoral cellular composition including stromal and immune components. The results of this collaboration highlight the powerful advantage of NGS data analysis in comparison to conventional techniques to more fully characterize the tumor.

Using small amounts of tissue, BostonGene provides an accurate, patient-tailored report for physicians. The report includes a visually-appealing and self-explanatory tumor schematics, called MF Portrait, depicting tumor activity, tumor cellular composition, activity of immune-microenvironment and other tumor-associated processes.

"Our collaboration with BostonGene is aimed at understanding the pathogenesis of each person’s cancer and ultimately having a positive impact on patient care by enabling personalized cancer treatments," said Mark Poznansky, MD, PhD, at Massachusetts General Hospital.

"BostonGene provides the solution necessary for oncologists to evaluate NGS data in combination with all relevant clinical knowledge to determine the best personalized care for the individual patient," said Andrew Feinberg, President and CEO of BostonGene. "We are excited to collaborate with VIC at MGH to demonstrate how our unique solution for tailored treatment options improves outcomes for cancer patients."